Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
122
1 country
1
Brief Summary
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 23, 2017
February 1, 2017
2.9 years
February 16, 2017
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
therapeutic success
A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.
From date of treatment until the date of completing treatment 1 month later
Study Arms (2)
Intensity-modulated Radiotherapy
EXPERIMENTALRadiotherapy alone was given.
Concurrent chemoradiotherapy
ACTIVE COMPARATORConcurrent cisplatin-based radiotherapy was given.
Interventions
Eligibility Criteria
You may qualify if:
- Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma
You may not qualify if:
- A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiaozhong Chen
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 23, 2017
Record last verified: 2017-02